Study of FibroGen (FG)-3019 in Subjects With Type 2 Diabetes Mellitus and Kidney Disease on ACEi and/or ARB Therapy

Sponsor

FibroGen (Industry)

Overall Status

Terminated

CT.gov ID

NCT00913393

Collaborator

(none)

Enrollment

Locations

Arms

15.9

Duration (Months)

1.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effect of FG-3019 on diabetic kidney disease or diabetic nephropathy.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus Diabetic Nephropathy Diabetic Kidney Disease	Drug: FG-3019 Drug: FG-3019 Drug: Placebo	Phase 2

Detailed Description

The primary objective of this study is to assess the effect of FG-3019 on proteinuria as assessed by urinary albumin/creatinine ratio (ACR).

Study Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase 2 Randomized, Double-blind, Placebo-controlled Study of FG-3019 in Subjects With Type 2 Diabetes Mellitus (DM) and Persistent Proteinuria on Background Angiotensin Converting Enzyme Inhibitor (ACEi) and/or Angiotensin II Receptor Blockade (ARB) Therapy

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1 Placebo IV	Drug: Placebo Placebo IV every 2 weeks for 22 weeks
Experimental: 2 3 mg/kg FG-3019 IV	Drug: FG-3019 3 mg/kg FG-3019 IV every 2 weeks for 22 weeks
Experimental: 3 10 mg/kg FG-3019 IV	Drug: FG-3019 10 mg/kg FG-3019 IV every 2 weeks for 22 weeks

Arm

Intervention/Treatment

Placebo Comparator: 1

Placebo IV

Drug: Placebo

Placebo IV every 2 weeks for 22 weeks

Experimental: 2

3 mg/kg FG-3019 IV

Drug: FG-3019

3 mg/kg FG-3019 IV every 2 weeks for 22 weeks

Experimental: 3

10 mg/kg FG-3019 IV

Drug: FG-3019

10 mg/kg FG-3019 IV every 2 weeks for 22 weeks

Outcome Measures

Primary Outcome Measures

Measure: change from baseline in 24-hour urinary ACR for each arm compared with placebo [6 months]

Secondary Outcome Measures

Measure: Safety and tolerability of FG-3019 in the study population. [12 months]
Measure: Change from baseline in eGFR for each FG-3019 arm compared to placebo [6 months]
Measure: Change from baseline in serum creatinine for each FG-3019 arm compared with placebo [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

Signed written informed consent
Males and females 18-75 years of age, inclusive
Diagnosis of type 2 diabetes mellitus according to American Diabetes Association (ADA) criteria
24-hour urinary ACR 200-3000 mg/g, inclusive, on two occasions during screening at least 2 days apart
Estimated glomerular filtration rate (eGFR) (by MDRD equation) >20 mL/min/1.73 m2
Mean systolic blood pressure less than or equal to 150 mmHg and a mean diastolic blood pressure less than or equal to 95 mmHg
Receiving ACEi and/or ARB therapy at an unchanged dose at or above the minimum trial dosage for at least 3 months prior to the first Screening visit and willing to maintain these doses throughout the treatment period

Key Exclusion Criteria:

Females who are pregnant or breast feeding
Organ transplant recipient, history of dialysis, or known non-diabetic renal disease other than benign cysts or anatomical variants
History of New York Heart Association class III/IV heart failure
Screening electrocardiogram showing acute and/or clinically significant findings including but not limited to ST depression
History of any of the following events within 3 months prior to Screening: coronary artery bypass graft, cerebrovascular accident, myocardial infarction, transient ischemic attack, unstable angina, uncontrolled cardiac arrhythmia, atrial fibrillation, percutaneous coronary intervention, or vascular stent placement
History of anaphylactic or systemic allergic reaction to human, humanized, chimeric, or murine monoclonal antibodies
Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5 times the upper limit of normal; direct bilirubin above the upper limit of normal, or >2.5 times the upper limit of normal in cases of documented Gilbert's syndrome
Hemoglobin <10 g/dL
Hemoglobin A1c (HbA1c) >9 %
Low density lipoprotein (LDL) >130 mg/dL

Contacts and Locations

Locations

	City	State	Country
1	Tempe	Arizona	United States
2	Buena Park	California	United States
3	Lakewood	California	United States
4	Sacramento	California	United States
5	Walnut Creek	California	United States
6	Whittier	California	United States
7	Atlanta	Georgia	United States
8	Evergreen Park	Illinois	United States
9	Topeka	Kansas	United States
10	Wichita	Kansas	United States
11	Kenner	Louisiana	United States
12	Springfield	Massachusetts	United States
13	Saint Clair Shores	Michigan	United States
14	Lincoln	Nebraska	United States
15	Omaha	Nebraska	United States
16	Berlin	New Jersey	United States
17	Buffalo	New York	United States
18	Flushing	New York	United States
19	New York	New York	United States
20	Greenville	North Carolina	United States
21	Toledo	Ohio	United States
22	Chattanooga	Tennessee	United States
23	Knoxville	Tennessee	United States
24	Dallas	Texas	United States
25	Houston	Texas	United States
26	San Antonio	Texas	United States
27	Fairfax	Virginia	United States
28	Spokane	Washington	United States